Periodontal Status in Patients With Chronic Skin Diseases

October 5, 2023 updated by: Hoa Ho Thi, University of Medicine and Pharmacy at Ho Chi Minh City

Periodontal Status in Patients With Chronic Skin Diseases: a Pilot Study

Objective: This study aimed to evaluate and compare the periodontal status of chronic skin disease (CSD) patients with healthy controls.

Material and method: 109 patients and 37 healthy subjects were included in this study. Parameters evaluated included bleeding on probing index (BOP), periodontal pocket depths (PPD), clinical attachment level (CAL), simplified debris index (DI), simplified calculus index (CI), and the presence of oral lesions. Clinical parameters were measured and compared in the two groups. The significant level was set at 0.05.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with CSDs (psoriasis, atopic dermatitis, autoimmune bullous diseases, or systemic lupus erythematosus,…) were diagnosed by the dermatologists with over 5 years of experience and supportive laboratory tests, aged 18 years or older, and willing to participate in the study. The control group included healthy individuals, aged 18 years or older and free of chronic skin diseases. These individuals were willing to participate in the study and would be used as a comparison group for the case group.

Clinical parameter collection Information related to epidemiological characteristics and chronic inflammatory skin conditions were recorded from medical records and oral health status was collected from clinical examination conducted by postgraduate doctors and lecturers of the Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City. The investigators were trained by a specialist in public dentistry and had intra-rater and inter-rater reliability of more than or equal to 0.8.

The following oral clinical parameters were evaluated:

  1. Full mouth bleeding on probing scores (BOP): BOP was recorded and considered positive when bleeding occurred within 20 seconds after the probe was removed after application with light pressure. A bleeding percentage was calculated for each patient by dividing the total number of positive bleeding sites by the total number of probed sites.
  2. Pocket probing depth (PPD) was measured from the gingival margin to the base of the gingival sulcus/ periodontal pocket with the aid of a University of North Carolina (UNC) 15-mm periodontal probe.
  3. Clinical attachment level (CAL) was measured from the cemento-enamel junction (CEJ) to the base of the gingival sulcus/ periodontal pocket with the aid of a UNC periodontal probe. The CAL was considered zero if the attachment was at the level of the CEJ. If the free gingival margin was coronal to the CEJ, the CAL was determined by measuring the PPD and subtracting the distance from the CEJ to the free gingival margin. When the free gingival margin was apical to the CEJ, the CAL was determined by measuring the distance from the CEJ to the free gingival margin and adding it to the PPD.
  4. debris index (DI), and (5) calculus index (CI), which were evaluated pertaining to the Simplified Oral Hygiene Index (OHI-S) as suggested by Green and Vermillion (1964)

(6) the number of oral lesions. Probed sites were classified into three different categories of PPD and CAL (≤ 3 mm, 4-5 mm, > 6mm).

The investigator examined one tooth (index teeth) from each sextant, including the incisor, left and right molar regions for both the maxillary and mandibular dental arches, to record the CAL, DI, and CI.

Statistics analysis All statistical analysis was performed using Jeffrey's Amazing Statistics Program (JASP) software, version 0.17.2.1 (University of Amsterdam, Amsterdam, The Netherlands). The normality of distribution of the data was verified using the Shapiro-Wilk test. For variables that were under normal distribution, independent t-test test was used for detecting the statistically significant differences among two groups. For variables that were not normally distributed, Mann-Whitney test was used to compare among two groups. P value of <0.05 was considered statistically significant.

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 70000
        • University of Medicine and Pharmacy at Ho Chi Minh City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

A prospective case-control study was conducted at Ho Chi Minh City Hospital of Dermato-Venereology in February 2023 to assess the periodontal status of patients with CSDs. The study included 109 patients with CSDs, including psoriasis, atopic dermatitis, lupus, and common autoimmune bullous skin diseases, and 37 healthy controls.

Description

Inclusion Criteria:

  • Patient CSDs:

    • were diagnosed in CSDs (psoriasis, atopic dermatitis, autoimmune bullous diseases, or systemic lupus erythematosus...) by the dermatologists with over 5 years of experience and supportive laboratory tests
    • aged 18 years or older
    • willing to participate in the study

  • Control group:

    • aged 18 years or older
    • free of chronic skin diseases

Exclusion Criteria:

  • Toothless
  • Limited mouth opening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control group
healthy individuals, aged 18 years or older and free of chronic skin diseases, willing to participate in the study
Diagnostic test: oral health status

  • CSDs medical records: Information related to epidemiological characteristics and chronic inflammatory skin conditions (psoriasis, atopic dermatitis, autoimmune bullous diseases, or systemic lupus erythematosus,…) were recorded from medical records:

    • Pemphigus
    • Mixed connective tissue disease
    • Atopic dermatitis
    • Psoriasis
    • Erythroderma

  • oral health status: oral clinical parameters were evaluated:

    • Full mouth bleeding on probing scores
    • Pocket probing depth
    • Clinical attachment level
    • debris index
    • calculus index
    • the number of oral lesions
Other Names:
  • CSDs medical records
Patients with CSDs
Patients with CSDs (psoriasis, atopic dermatitis, autoimmune bullous diseases, or systemic lupus erythematosus,…) were diagnosed by the dermatologists with over 5 years of experience and supportive laboratory tests, aged 18 years or older, and willing to participate in the study
Diagnostic test: oral health status

  • CSDs medical records: Information related to epidemiological characteristics and chronic inflammatory skin conditions (psoriasis, atopic dermatitis, autoimmune bullous diseases, or systemic lupus erythematosus,…) were recorded from medical records:

    • Pemphigus
    • Mixed connective tissue disease
    • Atopic dermatitis
    • Psoriasis
    • Erythroderma

  • oral health status: oral clinical parameters were evaluated:

    • Full mouth bleeding on probing scores
    • Pocket probing depth
    • Clinical attachment level
    • debris index
    • calculus index
    • the number of oral lesions
Other Names:
  • CSDs medical records

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full mouth bleeding on probing scores (BOP)
Time Frame: baseline
BOP was recorded and considered positive when bleeding occurred within 20 seconds after the probe was removed after application with light pressure. A bleeding percentage was calculated for each patient by dividing the total number of positive bleeding sites by the total number of probed sites
baseline
Pocket probing depth (PPD)
Time Frame: baseline
PPD was measured from the gingival margin to the base of the gingival sulcus/ periodontal pocket with the aid of a University of North Carolina (UNC) 15-mm periodontal probe
baseline
Clinical attachment level (CAL)
Time Frame: Baseline
was measured from the cemento-enamel junction (CEJ) to the base of the gingival sulcus/ periodontal pocket with the aid of a UNC periodontal probe. The CAL was considered zero if the attachment was at the level of the CEJ. If the free gingival margin was coronal to the CEJ, the CAL was determined by measuring the PPD and subtracting the distance from the CEJ to the free gingival margin. When the free gingival margin was apical to the CEJ, the CAL was determined by measuring the distance from the CEJ to the free gingival margin and adding it to the PPD
Baseline
debris index (DI)
Time Frame: Baseline
DI were evaluated pertaining to the Simplified Oral Hygiene Index (OHI-S) as suggested by Green and Vermillion (1964)
Baseline
calculus index (CI)
Time Frame: Baseline
CI were evaluated pertaining to the Simplified Oral Hygiene Index (OHI-S) as suggested by Green and Vermillion (1964)
Baseline
the number of oral lesions
Time Frame: Baseline
Probed sites were classified into three different categories of PPD and CAL (≤ 3 mm, 4-5 mm, > 6mm)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

  • Study Director: Hao Trong Nguyen, PhD, Ho Chi Minh City Hospital of Dermato-Venereology, Ho Chi Minh City, Vietnam
  • Study Director: Thuy Thu Nguyen, PhD, University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2023

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

April 28, 2023

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Estimated)

October 9, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HoChiMinhCityUMP_FOS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Study conception and design by groups of 8 researchers working at Ho Chi Minh City Hospital of Dermato-Venereology, Ho Chi Minh City, Vietnam and Faculty of Odonto-stomatology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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